Package Leaflet: Information for the User

Citalopram

10mg, 20mg and 40mg Tablets Read all of this leaflet carefully before you take this medicine.

•    Keep this leaflet. You may need to read it again.

•    This medicine has been prescribed for you. Do not pass it on to others, it may harm them, even if their symptoms are the same as yours.

Citalopram treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment.

Citalopram is not for use in children and adolescents under 18. See section 2, Use in children and adolescents aged 8 to 18 years. Citalopram won't work straight away. Some people taking antidepressants feel woise before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven't started feeling better. See section 3, How to take Citalopram tablets.

Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, orthink of harming or killing yourself, see your doctor or go to a hospital straight away.

See section 2.

Don't stop taking Citalopram without talking to your doctor.

If you stop taking Citalopram suddenly or miss a dose, you may get withdrawal effects. See section 3 for further information.

If you feel restless and feel like you can’t sit or stand still, tell your doctor. Increasing the dose of Citalopram may make these feelings worse. See section 4, Possible side-effects.

Taking some other medicines with Citalopram can cause problems. You may need to talk to your doctor. See section 2,

Other medicines and Citalopram Tablets.

If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, Pregnancy, breast-feeding and fertility.

What is in this leaflet:

1.    What Citalopram Tablets are and what they are used for

2.    What you need to know before you take Citalopram Tablets

3.    Mow to take Citalopram Tablets

4.    Possible side effects

5.    How to store Citalopram Tablets

6.    Contents of the pack and other information

[I] WHAT CITALOPRAM TABLETS ARE AND WHAT THEY ARE USED FOR

Citalopram belongs to a group of anti-depressants known as Selective Serotonin Re-uptake Inhibitors (SSRIs).

Citalopram is used to treat the symptoms of depression and, when you are feeling better, to help prevent these symptoms coming back.

It may also be used to relieve the symptoms of panic attacks.

[2] WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM TABLETS Do NOT take Citalopram Tablets if you:

•    are allergic (hypersensitive) to citalopram orany of the other ingredients (listed in section 6)

•    are taking monoamine oxidase inhibitors (MAOIs) such as selegiline, linezolid ormoclobemide, or have taken them within the last 2 weeks. You will need to wait for 2 weeks after you have finished taking the MAOI before starting your Citalopram Tablets. MAOIs should not be started for 7 days after stopping citalopram.

•    are bom with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning)

•    take medicines for heart rhythm problems or that may affect the heart's rhythm. Also refer to the section “Other medicines and Citalopram Tablets’.

•    are taking pimozide (an anti-epileptic medicine).

Warnings and precautions

Talk to your doctor before taking Citalopram Tablets if you:

•    have diabetes

•    have epilepsy or have seizures

•    have a history of mania or hypomania

•    are undergoing ECT (electroconvulsive therapy)

•    feel suicidal orhave thoughts of self harm

•    have or have had a bleeding disorder, a stomach ulcer or bleeding from the stomach or intestine

•    have psychotic symptoms

•    have any liver or kidney problems

•    have problems with your eyes, such as certain kinds of glaucoma

•    suffer or have suffered from heart problems or have recently had a heart attack

•    have a low resting heart rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)

•    experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal fonctioning of the heart rate.

Thoughts of suicide and worsening of your depression or anxiety disorder.

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may increase when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this if:

•    you have previously had thoughts about killing or harming yourself

•    you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, andaskthemto read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Use in children and adolescents under 18 years Citalopram should normally not be used in children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.

Despite this, your doctor may prescribe Citalopram for patients under 18 because he/she decides that this is in their best interests.

If your doctor has prescribed Citalopram for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Citalopram. Also the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Citalopram in this age group have not yet been demonstrated.

Other medicines and Citalopram Tablets Please tell your doctor or pharmacist if you are taking orhave recently taken any other medicines, including medicines obtained without a prescription.

Do not take Citalopram if you are taking:

•    monoamine oxidase inhibitors (see earlier in section 2)

•    St John’s Wort (a herbal remedy for depression)

•    medicines for heart rhythm problems or medicines that

may affect the heart’s rhythm, such as Class IA and III _

antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, -

pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

You should tell your doctor if you are taking:

•    metoprolol, used to treat heart conditions

•    cimetidine (for stomach ulcers)

•    mefloquine (for malaria)

•    neuroleptics used to treat schizophrenia

•    anticoagulants (drugs that thin the blood) oraspirin

•    non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac

•    some medicines (serotoneigics) used to treat pain or migraine (e.g. tramadol or sumatriptan) may be taken with citalopram, but if you feel unwell after taking these drugs, do not take them again

•    other antidepressants such as lithium, tryptophan, imipramine, desipramine or bupropion.

Taking Citalopram Tablets with food and alcohol Citalopram can be taken with orwithout food. You are advised not to drink alcohol during treatment with citalopram.

Pregnancy, breast-feeding and fertility Do not take Citalopram Tablets if you are, orthink you might be pregnant oryou are breast-feeding. Tell your doctor if you become pregnant or are planning to become pregnant during treatment with citalopram. The use of citalopram during the last 3 months of pregnancy can cause symptoms in the newborn baby. These include difficulty breathing, stiff or loose muscles, jitteriness, blue-ish skin, feeling too hot ortoo cold. If your baby gets any of these tell your doctor straight away. Make sure your midwife and/or doctor know you are on Citalopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new bom (PPHN), making the baby breathe fester and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

Citalopram has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility had not been observed as yet.

Driving and using machines

For most people, normal daily activities are not affected when taking citalopram. However, you should be careful when driving, operating machinery orwhen you need to be alert until you know how you react to your medicine.

Citalopram Tablets contain lactose monohydrate

This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Continued overleaf

\T\ HOW TO TAKE CITALOPRAM TABLETS

Always take your medicine exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure. Your doctor will decide the dose that is right for you.

•    Swallow the tablets with a drink of water - do not chew them.

Citalopram is not recommended for use in children (under 18 years).

How much to take:

Adults

•    Depression - The usual dose is 20 mg per day. This may be increased by your doctor to a maximum of 40 mg per day.

•    Panic disorder - The starting dose is 10 mg per day for the first week before increasing the dose to 20-30 mg per day. The dose may be increased by your doctor to a maximum of 40 mg per day.

Elderly patients (above 65 years of age)

•    The starting dose should be decreased to half of the recommended dose, e.g. 10-20 mg per day.

•    Elderly patients should not usually receive more than 20 mg per day.

Patients with special risks

•    Patients with liver complaints should not receive more than 20 mg per day.

It can take several days before you start to feel the benefit from Citalopram Tablets, this is normal for this type of medicine. Do not stop taking the medicine, orchange the dose, even if you feel better, unless your doctor tells you to.

If you continue to experience the symptoms of depression after 2-4 weeks, tell your doctor.

If you forget to take a dose take it as soon as you remember unless it is nearly time for your next dose. Do not take two doses at the same time.

Do not stop taking Citalopram Tablets suddenly, as this may cause withdrawal reactions. (See ‘Withdrawal symptoms' in section 4). The dose should be reduced gradually at intervals of 1-2 weeks.

If you take more Citalopram Tablets than you should tell your doctor at once or go to the nearest hospital casualty department. Take with you the container and any tablets that are left so that the hospital can easily tell what medicine you have taken.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

[T] POSSIBLE SIDE EFFECTS

Like all medicines, Citalopram Tablets can cause side effects, though not everybody gets them.

Side effects are usually mild and occur in the first few weeks of treatment but reduce as the depression improves.

Patients prone to panic attacks may experience a short period of heightened anxiety when starting treatment. This should reduce after 1-2 weeks.

Stop taking Citalopram and tell your doctor or go to the nearest hospital casualty immediately if you have any of the following serious side effects:

•    Swelling of the lips and face, skin rash, difficulty breathing (these may be symptoms of a serious allergic reaction).

•    Thoughts ofharming or killing yourself atany time.

•    Fast, irregular heartbeat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes

Tell your doctor as soon as possible if you:

•    Vomit blood or have blood stained or black stools. Very rarely, SSRIs may increase the risk of bleeding, including bleeding from the stomach or intestine.

•    Have high fever, sweating, confusion, abnormal movements, diarrhoea and muscle spasm. These may be symptoms of Serotonin syndrome which has been reported in patients treated with this type of antidepressant (SSRIs).

If any of the following side effects gets worse oryou are worried tell your doctor or pharmacist:

Very common side effects (affect more than 1 in 10 people)

•    Sleepiness, difficulty sleeping, changes in your sleeping pattern.

•    Dry mouth, nausea, increased sweating.

•    Headache

•    Weakness

Common side effects (affect less than 1 in 10 people)

•    Reduced appetite, weight loss

•    Agitation, anxiety, tremor, dizziness, nervousness, confusion, abnormal dreams

•    Ringing in the ears, yawning

•    Diarrhoea, constipation, vomiting

•    Itching, abnormal skin sensation

•    Muscle or joint pain

•    Impotence, reduced libido, failure to or problems with ejaculation, inability to reach orgasm in women

■ Fatigue, impaired concentration

•    Migraine

•    Palpitations

•    Loss of memory (amnesia)

•    Reduced emotions, indifference (apathy)

•    Blocked or runny nose (rhinitis)

•    Indigestion

•    Stomach pain

•    Flatulence (wind)

•    Increase in saliva (drooling)

•    Anorexia

Uncommon side effects (affect less than 1 in 100 people)

•    Purple discolouration of the skin, rash, hair loss

•    Increased appetite, weight increase, fluid retention

•    Aggression, feeling of unreality, hallucination, mania (severe mood swings)

•    Fainting, slow orfast heart rate

•    Urine retention

•    Sensitivity to light

•    Heavy and prolonged periods

•    Eye sight problems, which may lead to glaucoma.

•    Increased sex drive

Rare side effects (affect less than 1 in 1000 people)

•    Low blood levels of sodium

•    Convulsion, abnormal involuntary movement, fever

•    Liver problems (hepatitis)

•    Taste disturbance

•    Bleeding.

•    Feeling unwell (malaise)

•    Coughing

Other side effects (frequency unknown):

•    Hypersensitivity reactions (see earlier) orswelling of the skin.

•    Syndrome of inappropriate ADH secretion (SIADH) symptoms are confusion, hallucinations, drowsiness, fits, coma, breathing difficulties

•    Panic attack, tooth grinding, restlessness, suicidal thoughts and behaviour

•    Convulsions, serotonin syndrome (see earlier), movement disorders, involuntary movements

•    Abnormal vision

•    Low blood pressure causing dizziness orfeeling faint on standing

•    Nose bleed, bleeding between periods, other bleeding disorders

•    Bleeding from the stomach, intestines or rectum

•    Reduced blood platelets increasing the risk of bruising orbleeding

•    Persistent erection

•    Secretion of breast milk in men or in women who are not breast feeding

>    Abnormal liver function tests

•    Heart ECG changes (increased QT interval)

•    Low level of potassium in the blood

>    An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you do experience side effects these usually disappear after a few days oftreatment. If they are troublesome or persistent, or if you have unusual effects whilst taking citalopram, tell your doctor.

Withdrawal symptoms

These may occur if treatment is stopped suddenly. Symptoms include dizziness, pins and needles, trouble sleeping with bad dreams, agitation/anxiety, nausea, vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional problems, irritability and visual disturbances. Generally these symptoms improve within 2 weeks.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

|j] HOW TO STORE CITALOPRAM TABLETS

Keep this medicine out of the sight and reach of children

Do not store above 25°C. Store in the original package.

Do not use after the expiry date, which is stated on the blister strip and carton. The expiry date refers tothe last day ofthat month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

[1] CONTENTS OF THE PACK AND OTHER INFORMATION

What Citalopram Tablets contain

•    Each tablet contains 10mg, 20mg or40mg ofthe active substance citalopram (as citalopram hydrobromide).

•    The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, maize starch, glycerol, copovidone, magnesium stearate, hypromellose, polyoxyethylene stearate and titanium dioxide.

What Citalopram Tablets look like and contents ofthe pack

The tablets are white and round, marked with ‘CIT/10’, ‘CIT/20’ or 'CIT/40' on one side and plain on the other.

Each pack contains 14 or 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer M&A Pharmachem Ltd, Bolton, Lancashire BL5 2AL.

This leaflet was last revised in 03/2015.

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